To evaluate adverse effects after every course of chemotherapy according to NCI-CTCAE V3. [ Time Frame: 1 year (from patient registration until 28 days after last study drug administration). ] [ Designated as safety issue: No ]

To identify any dose limiting toxicities of Capecitabine [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:

13

Study Start Date:

November 2009

Study Completion Date:

August 2012

Primary Completion Date:

August 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: capecitabine

film-coated tablet 1250 mg/m2 twice daily for 14 days every 3 weeks. Number of cycles: 8 cycles unless there is evidence of disease progression, or unacceptable toxicity

Other Name: Xeloda

Detailed Description:

Primary Objective:

To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone proximal pancreatico-duodenectomy.

Secondary objectives:

To establish the toxicity profile of capecitabine in these patients and to identify any dose limiting toxicities (DLT).

To ensure equivalent capecitabine exposure when compared to previous studies using patients who have not undergone such surgery.

This is a clinical trial to evaluate the pharmacokinetics (PK) of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy. The study also aims to establish the toxicity profile of capecitabine in these patients, to identify any dose limiting toxicities (DLT), and to ensure equivalent capecitabine exposure when compared to previous studies using patients who have not undergone such surgery. Screening tests will consist of demographic details, complete medical history, physical exam, vital signs, tumour serum markers, haematology and biochemistry tests. There will also be an ECG, faecal elastase measurement and a serum or urine pregnancy test (for women of childbearing potential). Haematology and Biochemistry (including CA19.9) will be repeated prior to each study drug administration. All patients will receive 8 cycles of oral capecitabine chemotherapy at a dose of 1250 mg/m2, administered twice daily at 12 hourly intervals for 14 consecutive days out of a 21 day cycle. Total proposed duration of therapy is 24 weeks, assuming patients commence all cycles without delay. Capecitabine and its metabolites (DFCR, DFUR and 5-FU) plasma levels will be measured during the 1st and 3rd cycles in all patients. Treatment should continue for 8 cycles unless there is evidence of disease progression, or unacceptable toxicity.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Surgery included proximal pancreatico-duodenectomy

Complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection)

Histological confirmation of the primary diagnosis and examination of all resection margins

At least 4 weeks since surgery, fully recovered from the operation and fit to take part in the trial

Female patients of child-bearing potential must have a negative serum pregnancy test prior to enrolment and agree to use appropriate medically approved contraception for four weeks prior to entering the trial, during the trial and for six months afterwards.

Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards.

Written, informed consent provided.

Ability of the patient to co-operate with treatment and follow up must be ensured and documented.

Exclusion Criteria:

Pregnancy or Lactation

Evidence of malignant ascites, peritoneal or liver metastasis, spread to other distant abdominal or extra-abdominal organs.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854477